Forest Laboratories, Inc. and Gedeon Richter Plc. Announce Positive Phase
IIb Topline Results for Cariprazine for the Treatment of Bipolar Depression
Business Wire
NEW YORK & BUDAPEST, Hungary -- March 31, 2014
Forest Laboratories, Inc. (NYSE:FRX) and Gedeon Richter Plc. today announced
positive topline results from a Phase IIb trial evaluating the efficacy and
safety of the investigational antipsychotic cariprazine in patients with
bipolar depression.
The trial consisted of four treatment groups: cariprazine 0.75 mg/day, 1.5
mg/day, 3.0 mg/day, and placebo. Statistically significant improvements were
observed in the cariprazine 1.5 mg/day group relative to placebo at 6 weeks
for the primary endpoint, the Montgomery-Asberg Depression Rating Scale
(MADRS) total score and the key secondary endpoint, the Clinical Global
Impressions – Severity (CGI-S) score.
“We are pleased with the positive results of this study. In addition to
previously completed Phase III trials in schizophrenia and bipolar mania, we
now have positive Phase IIb studies for cariprazine in both bipolar depression
and major depressive disorder. Our goal is to continue developing cariprazine
for patients with a broad range of psychiatric conditions,” said Marco
Taglietti, M.D., Executive Vice President of Drug Development and Research at
Forest Laboratories, Inc.
“Cariprazine is a critical element to Richter’s discovery platform,” explained
Dr. Zsolt Szombathelyi, Research Director of Gedeon Richter Plc. “We are
pleased with the topline results of the Phase IIb trial and are committed to
developing an important new treatment option for patients suffering from
bipolar depression.”
About this Phase IIb Study
This international, randomized, placebo-controlled, fixed-dose, 8-week Phase
IIb trial evaluated the efficacy and safety of cariprazine in the treatment of
patients with depressive episodes of bipolar I disorder. Eligible patients
included those with bipolar depression who met the Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria
for bipolar I disorder with a current major depressive episode. Patients also
had to have a minimum score of 20 on the 17-item Hamilton Depression Rating
Scale (HAM-D), a minimum score of 2 on item 1 of the HAM-D, a minimum score of
4 on the CGI-S, and a maximum score of 10 on the Young Mania Rating Scale
(YMRS) at both visit 1 and visit 2.
The study consisted of up to 14 days of screening followed by 8 weeks of
double-blind treatment, followed by a 1-week safety follow-up period. During
the double-blind treatment period, 584 patients 18 – 65 years of age were
randomized to one of four treatment groups: cariprazine 0.75 mg/day, 1.5
mg/day, 3.0 mg/day, or placebo. The primary endpoint was change from baseline
in the MADRS total score versus placebo at 6 weeks, using a mixed-effects
model for repeated measures (MMRM) analysis. The group who received
cariprazine 1.5 mg/day demonstrated statistically significant improvement in
the MADRS total score versus placebo at week 6 (cariprazine 0.75 mg/day: -1.9,
p=0.1292; cariprazine 1.5 mg/day: -4.0, p=0.0030; cariprazine 3.0 mg/day:
-2.5, p=0.1122).
The key secondary endpoint was change from baseline in CGI-S total score
versus placebo at 6 weeks, using an MMRM analysis. The group who received
cariprazine 1.5 mg/day demonstrated statistically significant improvement in
the CGI-S score versus placebo (cariprazine 0.75 mg/day: -0.1, p=0.3025;
cariprazine 1.5 mg/day: -0.4, p=0.0132; cariprazine 3.0 mg/day: -0.3,
p=0.1122).
Across all cariprazine doses, the most common adverse events (incidence ≥10%
and greater than placebo) were akathisia and insomnia.
About Cariprazine
Cariprazine, an investigational drug, is an orally active, potent dopamine
D[3]-preferring D[3]/D[2] receptor partial agonist atypical antipsychotic. It
has a low affinity at other receptor sites such as 5-HT[2C], muscarinic, and
adrenergic receptor sites. Cariprazine is protected by a composition-of-matter
patent that expires in 2027 without patent term extension.
Cariprazine is being developed for the treatment of schizophrenia and bipolar
mania in adults. On November 21, 2013 the companies announced that the U.S.
Food and Drug Administration issued a complete response letter regarding the
new drug application for schizophrenia and bipolar mania. In addition,
cariprazine is being investigated for the treatment of bipolar depression and
as adjunctive treatment for major depressive disorder in adults.
About Bipolar I Disorder
Bipolar disorder, which encompasses bipolar I and bipolar II disorders,
affects approximately 5.7 million people in the U.S. Bipolar I disorder, also
known as manic-depressive illness, is characterized by unusual shifts in mood,
energy, activity levels, and the ability to carry out day-to-day tasks.
Patients experience "mood episodes" that manifest as either a manic episode
(overexcited, extreme irritability, racing thoughts, and difficulties with
sleep) or a depressive episode (extreme sadness, fatigue, or hopelessness), or
a combination of both. Depression that occurs in patients with bipolar
disorder is called “bipolar depression.”
About Gedeon Richter Plc.
Gedeon Richter Plc. (www.richter.hu) headquartered in Budapest/Hungary, is a
major pharmaceutical company in Central Eastern Europe, with an expanding
direct presence in Western Europe. Richter’s consolidated sales
wereapproximately EUR1.2billion (USD1.6billion) while its market
capitalization amounted to EUR2.8billion (USD3.8billion) in 2013. The
product portfolio of the Company covers almost all important therapeutic
areas, including gynecology, central nervous system, and cardiovascular.
Having the largest R&D unit in Central Eastern Europe, the Company’s original
research activity focuses on CNS disorders. With its widely acknowledged
steroid chemistry expertise, Richter is a significant player in the female
healthcare field worldwide. Richter is also active in the scope of biosimilar
product development.
About Forest Laboratories
Forest Laboratories (NYSE:FRX) is a leading, fully integrated, specialty
pharmaceutical company largely focused on the United States market. The
Company markets a portfolio of branded drug products and develops new
medicines to treat patients suffering from diseases principally in the
following therapeutic areas: central nervous system, cardiovascular,
gastrointestinal, respiratory, anti-infective, and cystic fibrosis. Our
strategy of acquiring product rights for development and commercialization
through licensing, collaborative partnerships, and targeted mergers and
acquisitions allows us to take advantage of attractive late-stage development
and commercial opportunities, thereby managing the risks inherent in drug
development. The Company is headquartered in New York, NY. To learn more,
visit www.FRX.com.
Except for the historical information contained herein, this release contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals, the
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings. Forest assumes no obligation to update
forward-looking statements contained in this release to reflect new
information or future events or developments.
Contact:
Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice President - Investor Relations
media.relations@frx.com
or
Amanda Kaufman
Media Relations
amanda.kaufman@frx.com